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Infant Formula and Toddler Drink Feeding Intervention

Primary Purpose

Respiratory Infections in Children

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control Infant Formula
Control Toddler Drink
Experimental Infant Formula
Experimental Toddler Drink
Supplemental Formula for HM Group
Toddler Drink for HM group
Sponsored by
Abbott Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Respiratory Infections in Children

Eligibility Criteria

undefined - 14 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participant is judged to be in good health as determined from participant's medical history
  • Participant is a singleton from a full-term birth with a gestational age of 37 - 42 weeks
  • Participant's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)
  • If parent(s) elect to formula feed the participant they confirm their intention to feed their participant the study product as the sole source of feeding until 4 months of age, and as the sole milk beverage during the first 12 months of life
  • If parent(s) elect to formula feed the participant, they confirm their intention to feed the participant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage
  • If parent(s) elect to feed the participant mother's human milk, they confirm that their infant was exclusively fed mother's human milk since birth and confirm their intention to continue exclusively feeding human milk as the sole source of feeding through 4 months of age
  • If parent(s) of human milk fed participant elect to supplement or wean after 4 months to 24 months of age, they confirm their intention to use the supplemental/weaning formula or toddler drink as the primary milk beverage
  • Parent(s) of formula-fed participant confirm their intention not to administer vitamin or mineral supplements, from enrollment through the duration of the study
  • Parent(s) confirm their intention not to administer solid foods or juices to the participant from enrollment through 6 months of age
  • Participant's parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

  • An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development
  • Participant is taking and plans to continue medications (including over the counter (OTC), home remedies, herbal preparations, prebiotics or probiotics, or rehydration fluids that might affect GI tolerance
  • Participant is in another study that has not been approved as a concomitant study
  • Participant has been treated with antibiotics prior to enrollment

Sites / Locations

  • Southeastern Pediatric Associates
  • Eclipse Clinical Research
  • The Children's Clinic of Jonesboro, P.A.
  • Applied Research Center of Arkansas
  • Boeson Research 3266
  • TOPAZ Clinical Research, Inc.
  • ASCLEPES Research Centers
  • Meridian Clinical Research 3259
  • Clinical Research Prime
  • Leavitt Clinical Research
  • Qualmedica Research 3272
  • Deaconess Clinic, Inc.
  • Qualmedica Research, LLC 3270
  • Meridian Clinical Research 3080
  • Boeson Research 3265
  • Boeson Research 3267
  • Meridian Clinical Research 3264
  • Meridian Clinical Research 3263
  • Ohio Pediatric Research Association
  • Cyn3rgy Research
  • Holston Medical Group
  • MultiCare Institute for Research & Innovation
  • Maximos Ob/Gyn
  • DCOL Center for Clinical Research
  • PAS Research 3273
  • Multicare Rockwood Pediatrics
  • Mercury Clinical Research 3261

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Other

Arm Label

Control Feeding Group

Experimental Feeding Group

Human Milk (HM) Reference Group

Arm Description

Ready to feed milk-based product

Ready to feed milk-based product with oligosaccharides

HM from infant's own mother and as needed supplemental infant formula and toddler milk-based product

Outcomes

Primary Outcome Measures

Incidence of respiratory infection between study groups
Adverse event reports

Secondary Outcome Measures

Infection morbidity between study groups
Adverse event reports

Full Information

First Posted
July 29, 2020
Last Updated
May 12, 2021
Sponsor
Abbott Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT04495738
Brief Title
Infant Formula and Toddler Drink Feeding Intervention
Official Title
Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Change in research focus
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
April 12, 2021 (Actual)
Study Completion Date
April 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this randomized, multi-center, controlled, double-blind, parallel study is to evaluate the health and developmental outcomes of children fed a new infant formula and toddler drink through 24 months of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Infections in Children

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Feeding Group
Arm Type
Active Comparator
Arm Description
Ready to feed milk-based product
Arm Title
Experimental Feeding Group
Arm Type
Experimental
Arm Description
Ready to feed milk-based product with oligosaccharides
Arm Title
Human Milk (HM) Reference Group
Arm Type
Other
Arm Description
HM from infant's own mother and as needed supplemental infant formula and toddler milk-based product
Intervention Type
Other
Intervention Name(s)
Control Infant Formula
Intervention Description
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
Intervention Type
Other
Intervention Name(s)
Control Toddler Drink
Intervention Description
16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
Intervention Type
Other
Intervention Name(s)
Experimental Infant Formula
Intervention Description
Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
Intervention Type
Other
Intervention Name(s)
Experimental Toddler Drink
Intervention Description
16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
Intervention Type
Other
Intervention Name(s)
Supplemental Formula for HM Group
Intervention Description
Ad libitum formula given up to 12 months of age if HM is supplemented
Intervention Type
Other
Intervention Name(s)
Toddler Drink for HM group
Intervention Description
16 fl oz per day if weaned from HM feedings
Primary Outcome Measure Information:
Title
Incidence of respiratory infection between study groups
Description
Adverse event reports
Time Frame
Study Day 1 to 6 Months of Age
Secondary Outcome Measure Information:
Title
Infection morbidity between study groups
Description
Adverse event reports
Time Frame
Study Day 1 to 24 Months of Age
Other Pre-specified Outcome Measures:
Title
Weight
Description
Weight in grams
Time Frame
Study Day 1 to 24 Months of Age
Title
Length
Description
Length in cm
Time Frame
Study Day 1 to 24 Months of Age
Title
Head Circumference (HC)
Description
HC in cm
Time Frame
Study Day 1 to 24 Months of Age
Title
Gastrointestinal Tolerance
Description
Parent completed diary
Time Frame
Study Day 1 to 119 Days of Age
Title
Dietary Intake
Description
Parent completed diary
Time Frame
Study Day 1 to 24 Months of Age
Title
Infant Feeding and Stool Patterns Questionnaire
Description
Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction
Time Frame
28 Days of Age to 119 Days of Age
Title
Infant Behavior Questionnaire
Description
Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled in the negative direction
Time Frame
119 Days of Age
Title
Formula Satisfaction Questionnaire
Description
Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction
Time Frame
28 Days of Age to 6 Months of Age
Title
Toddler Drink Satisfaction Questionnaire
Description
Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction
Time Frame
15 Months of Age to 24 Months of Age
Title
Human Milk Sample
Description
Oligosaccharide characterization
Time Frame
84 Days of Age
Title
Stool Sample
Description
Microbiota characterization
Time Frame
Study Day 1 to 24 Months of Age
Title
Saliva Sample
Description
Maternal-Infant secretor status
Time Frame
84 Days of Age
Title
Modified Home Short Form
Description
Parent completed questionnaire; 8 questions related to the home environment adapted from the HSF compared between groups
Time Frame
6 Months of Age to 24 Months of Age
Title
Behavioral Questionnaire
Description
Parent completed questionnaire; 8 questions related to sleep, physical activity and screen time
Time Frame
12 Months of Age to 24 Months of Age
Title
Ages & Stages Questionnaire
Description
Parent completed questionnaire; 5 Developmental areas; Scores to the six questions in each area are totaled; Higher scores indicate more positive outcomes
Time Frame
6 Months of Age to 18 Months of Age
Title
Bayley Scale of Infant & Toddler Development
Description
Examiner rated assessment; Scores are totaled and compared to normative age group data and between groups
Time Frame
12 Months of Age to 24 Months of Age
Title
MacArthur Communicative Developmental Inventory
Description
Parent completed questionnaire of Words and Gestures and Words and Sentences; Percentiles compared to normative group data and between groups
Time Frame
12 Months of Age to 24 Months of Age
Title
Edinburgh Postnatal Depression Scale
Description
Mother completed questionnaire; Scores for each of the 10 items are totaled; Higher scores indicate more depressive symptoms
Time Frame
28 Days of Age
Title
Medications
Description
Medication usage including frequency and reason for use
Time Frame
Study Day 1 to 24 Months of Age
Title
Adverse Events
Description
Standard Adverse Event reporting
Time Frame
Study Day 1 to 24 Months of Age
Title
Health Resource Utilization
Description
Number of visits
Time Frame
Study Day 1 to 24 Months of Age

10. Eligibility

Sex
All
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant is judged to be in good health as determined from participant's medical history Participant is a singleton from a full-term birth with a gestational age of 37 - 42 weeks Participant's birth weight was ≥ 2490 g (~5 lbs. 8 oz.) If parent(s) elect to formula feed the participant they confirm their intention to feed their participant the study product as the sole source of feeding until 4 months of age, and as the sole milk beverage during the first 12 months of life If parent(s) elect to formula feed the participant, they confirm their intention to feed the participant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage If parent(s) elect to feed the participant mother's human milk, they confirm that their infant was exclusively fed mother's human milk since birth and confirm their intention to continue exclusively feeding human milk as the sole source of feeding through 4 months of age If parent(s) of human milk fed participant elect to supplement or wean after 4 months to 24 months of age, they confirm their intention to use the supplemental/weaning formula or toddler drink as the primary milk beverage Parent(s) of formula-fed participant confirm their intention not to administer vitamin or mineral supplements, from enrollment through the duration of the study Parent(s) confirm their intention not to administer solid foods or juices to the participant from enrollment through 6 months of age Participant's parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study. Exclusion Criteria: An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development Participant is taking and plans to continue medications (including over the counter (OTC), home remedies, herbal preparations, prebiotics or probiotics, or rehydration fluids that might affect GI tolerance Participant is in another study that has not been approved as a concomitant study Participant has been treated with antibiotics prior to enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bridget Barrett Reis, PhD, RD
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
Southeastern Pediatric Associates
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Eclipse Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
The Children's Clinic of Jonesboro, P.A.
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Applied Research Center of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72019
Country
United States
Facility Name
Boeson Research 3266
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81505
Country
United States
Facility Name
TOPAZ Clinical Research, Inc.
City
Apopka
State/Province
Florida
ZIP/Postal Code
32703
Country
United States
Facility Name
ASCLEPES Research Centers
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Facility Name
Meridian Clinical Research 3259
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Clinical Research Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Leavitt Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Qualmedica Research 3272
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Facility Name
Deaconess Clinic, Inc.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47725
Country
United States
Facility Name
Qualmedica Research, LLC 3270
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Meridian Clinical Research 3080
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Facility Name
Boeson Research 3265
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Boeson Research 3267
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Meridian Clinical Research 3264
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Meridian Clinical Research 3263
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Facility Name
Ohio Pediatric Research Association
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Cyn3rgy Research
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
MultiCare Institute for Research & Innovation
City
Dickinson
State/Province
Texas
ZIP/Postal Code
77539
Country
United States
Facility Name
Maximos Ob/Gyn
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
DCOL Center for Clinical Research
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
PAS Research 3273
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
Facility Name
Multicare Rockwood Pediatrics
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Mercury Clinical Research 3261
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Infant Formula and Toddler Drink Feeding Intervention

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